Clinical trial · Interventional
Iceland Screens, Treats or Prevents Multiple Myeloma
NCT03327597CI-TRIAL-00095954iStopMMactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the benefits and harms of screening for monoclonal gammopathy of undetermined significance (MGUS). The overall and disease-specific mortality will be compared between screened and not screened participants. All individuals registered as inhabitants in Iceland and born in 1975 or earlier have been invited to participate. The hypothesis is that an early detection of multiple myeloma (MM), through follow-up of MGUS, will improve overall survival and decrease complications associated with diagnosis and treatment of MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance | Monoclonal Gammopathy of Undetermined Significance | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical follow-up 1 | Other | — | UNRESOLVED |
| Clinical follow-up 2 | Other | — | UNRESOLVED |
| Clinical follow-up 3 | Other | — | UNRESOLVED |
| Clinical follow-up control | Other | — | UNRESOLVED |
| Mental Health and Quality of Life questionnaire | Other | — | UNRESOLVED |
| Standard follow-up or treatment. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- Abnormal Non-MGUS
- description
- Participants previously diagnosed with MGUS, multiple myeloma or other lymphoproliferative disease.
- interventionNames
- Other: Mental Health and Quality of Life questionnaire
- Other: Standard follow-up or treatment.
- type
- EXPERIMENTAL
- label
- MGUS group arm 1
- description
- Participants diagnosed with MGUS, randomized to group 1.
- interventionNames
- Other: Clinical follow-up 1
- Other: Mental Health and Quality of Life questionnaire
- type
- EXPERIMENTAL
- label
- MGUS group arm 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Born 1975 or earlier * With registered address in Iceland on November 1st 2016 Exclusion Criteria: * Prior multiple myeloma * Lymphoproliferative disease * Amyloidosis * M-protein \>30 g/L or involved:uninvolved serum FLC ratio \>100 Individuals with prior history of MGUS will be offered to be randomized into either moderate or intensive clinical follow-up (arms 2 or 3).
References
Publications (4)
- DERIVEDRognvaldsson S, Thorsteinsdottir S, Eythorsson E, Wessman ID, Sigurdardottir GA, Vidarsson B, Onundarson PT, Agnarsson B, Sigurdardottir M, Olafsson I, Thorsteinsdottir I, Bjornsson AS, Oskarsson JT, Olafsson A, Gislason G, Sverrisdottir I, Long TE, Guethmundsdottir ER, Thordardottir AR, Jonsson A, Palsson R, Indridason OS, Hultcrantz M, Durie BGM, Harding SJ, Aspelund T, Landgren O, Love TJ, Kristinsson SY. Clinical and Psychological Outcomes After Monoclonal Gammopathy Screening: A Population-Based Screening Study and Subsequent Randomized Trial of Follow-Up. J Clin Oncol. 2026 Jul 14:JCO2502771. doi: 10.1200/JCO-25-02771. Online ahead of print. PMID 42447419
- DERIVEDEythorsson E, Rognvaldsson S, Thorsteinsdottir S, Einarsson Long T, Reed ER, Sigurdardottir GA, Vidarsson B, Onundarson PT, Agnarsson BA, Sigurdardottir M, Olafsson I, Thorsteinsdottir I, Sveinsdottir SV, Sigurdsson F, Thordardottir AR, Palsson R, Indridason OS, Jonsson A, Gislason GK, Olafsson A, Sigurdsson J, Steingrimsdottir H, Hultcrantz M, Durie BGM, Harding S, Landgren O, Aspelund T, Love TJ, Kristinsson SY. Development of a Multivariable Model to Predict the Need for Bone Marrow Sampling in Persons With Monoclonal Gammopathy of Undetermined Significance : A Cohort Study Nested in a Clinical Trial. Ann Intern Med. 2024 Apr;177(4):449-457. doi: 10.7326/M23-2540. Epub 2024 Apr 2. PMID 38560901
- DERIVEDSigurbergsdottir AY, Rognvaldsson S, Thorsteinsdottir S, Sverrisdottir I, Sigurethardottir GA, Vietharsson B, Onundarson PT, Agnarsson BA, Sigurethardottir M, Thornorsteinsdottir I, Olafsson I, Thornorethardottir AR, Gislason GK, Olafsson A, Hultcrantz M, Durie BGM, Harding S, Landgren O, Love TJ, Kristinsson SY. Disease associations with monoclonal gammopathy of undetermined significance can only be evaluated using screened cohorts: results from the population-based iStopMM study. Haematologica. 2023 Dec 1;108(12):3392-3398. doi: 10.3324/haematol.2023.283191. PMID 37439374
- DERIVEDThorsteinsdottir S, Gislason GK, Aspelund T, Rognvaldsson S, Oskarsson JThorn, Sigurethardottir GA, Thornorethardottir AR, Vietharsson B, Onundarson PT, Agnarsson BA, Sigurethardottir M, Thornorsteinsdottir I, Olafsson I, Eythornorsson E, Jonsson A, Berlanga O, Hultcrantz M, Durie BGM, Love TJ, Harding S, Landgren O, Kristinsson SY. Prevalence of smoldering multiple myeloma based on nationwide screening. Nat Med. 2023 Feb;29(2):467-472. doi: 10.1038/s41591-022-02183-6. Epub 2023 Feb 6.